Delhi HQ · HPLC + HPTLC · ICH Q2(R1) Validated · NABL Accredited

Marker Compound Analysis for Herbal and AYUSH Products

Quantitative label claims on AYUSH and herbal supplement products — "standardised to 5% withanolides", "95% curcuminoids", "10% andrographolide" — require analytical evidence against a certified reference standard. Without a NABL-accredited marker compound assay, the claim is unsubstantiated: ASCI advertising orders, marketplace delisting, CDSCO regulatory action, and AYUSH licence dossier rejection all follow. Auriga Research provides quantitative HPLC and HPTLC marker compound analysis for the full range of Ayurvedic, Unani, Siddha, and Homeopathy actives, against the API, UPI, SPI, USP, and EP monographs that apply.

Our scope covers the marker compound layer that follows phytochemical screening — once the class is confirmed present, the named marker is quantified. Routine assay panels include withanolides (ashwagandha), curcuminoids (turmeric), andrographolide (kalmegh), piperine (black pepper), gymnemic acid (gymnema), boswellic acids (salai guggul), glycyrrhizin (licorice), bacosides (brahmi), ginsenosides (ginseng), centellosides (Centella), and other named pharmacopoeial markers. Custom marker method development plus full ICH Q2(R1) validation is available for proprietary actives or botanicals where the monograph is silent.

Testing is performed at our Delhi HQ (Arbro Analytical Division, NABL TC-7375) — India's first herbal testing lab licensed by the Directorate of ISM&H, AYUSH approved since 2004 (DTL-01 A&U), and holder of the Unani licence. HPLC platforms across the Arbro Group provide capacity for routine, high-volume batch-release marker assay; HPTLC pairs alongside for the pharmacopoeial chromatographic confirmation. Backed by the Arbro Group's unbroken NABL ISO/IEC 17025:2017 accreditation since 2003, reports are accepted by the Ministry of AYUSH, CDSCO, state AYUSH licensing authorities, ASCI for label claim substantiation, and EU / US / Gulf / ASEAN export regulators.

Established-method marker assay 5 to 7 business days | Custom method dev + ICH Q2(R1) validation 4 to 6 weeks

Six Marker Compound Categories

Each card lists the chemical category, the named markers within that category, and the example botanicals where the marker is the primary label-claim driver.

Triterpenes

Triterpene & Steroidal Markers

Withanolides (ashwagandha — Withania somnifera), gymnemic acid (Gymnema sylvestre), boswellic acids (Boswellia serrata salai guggul), centellosides (Centella asiatica), and related triterpenoid markers by HPLC.

Polyphenols

Polyphenolic & Curcuminoid Markers

Total curcuminoids (curcumin, demethoxycurcumin, bisdemethoxycurcumin in turmeric), tannins, gallic acid, ellagic acid, EGCG and other catechins in green tea, and polyphenolic markers by HPLC with UV / DAD.

Diterpenes

Diterpene Markers

Andrographolide and neoandrographolide (kalmegh — Andrographis paniculata), forskolin (Coleus forskohlii), tinosporaside (giloy — Tinospora cordifolia), and related diterpene markers by HPLC.

Alkaloids

Alkaloid Markers

Piperine (Piper nigrum / longum), berberine (Berberis aristata daruharidra), reserpine (Rauwolfia serpentina), vasicine (Adhatoda vasica), and other quantified alkaloid markers by HPLC with UV.

Glycosides

Glycoside & Saponin Markers

Glycyrrhizin (Glycyrrhiza glabra licorice), ginsenosides (Panax ginseng), bacosides (Bacopa monnieri brahmi), shatavarins (Asparagus racemosus shatavari), and other glycoside markers by HPLC.

Custom

Custom Marker Method Development

Method development plus full ICH Q2(R1) validation (specificity, linearity, accuracy, precision, LOD, LOQ, robustness) for proprietary markers or botanicals where the API / UPI / SPI / USP / EP monograph is silent.

Three-layer herbal characterisation: (1) Phytochemical Screening identifies which classes are present (qualitative). (2) Marker Compound Analysis (this page) quantifies specific named markers. (3) Standardisation & Fingerprinting bundles identity, HPTLC fingerprint matching, and marker assay into the pharmacopoeial-standardisation package for AYUSH licence dossiers.

How It Works

1

Get a Quote

Share the botanical, the named marker(s) you need quantified, the AYUSH / pharmacopoeial framework (API / UPI / SPI / USP / EP), the purpose (label claim, batch release, AYUSH licence dossier, ASCI substantiation), and whether method development is required. Your dedicated SPOC confirms the analytical method, the reference standard source, and the sample quantity required before you dispatch.

2

Send Your Sample

Dispatch the raw material, extract, or finished AYUSH product with a completed Test Request Form to the Delhi HQ (Arbro Analytical Division) lab. Each sample is bar coded and registered in YLIMS, Auriga's in-house Laboratory Information Management System, upon receipt. Sample preparation per the validated method begins within 24 hours of registration.

3

Quantitative HPLC / HPTLC Analysis and QA Review

Your sample is analysed by HPLC with UV, DAD, or fluorescence detection (or LC-MS/MS where the marker concentration is at trace level) against a certified reference standard. HPTLC chromatographic confirmation runs in parallel where the AYUSH or USP monograph requires it. Quantitation is reported as percentage content (w/w) and milligrams per gram or per dose. Every result is interpreted against the per-preparation monograph limit and passes formal internal QA review and sign-off before the report is generated.

4

Receive Your NABL Report

Your NABL-accredited marker compound report is delivered digitally within the committed turnaround time. Reports cite the analytical method, the reference standard, the named marker(s) quantified, the percentage content, and the compliance verdict against the monograph or claim. Accepted by Ministry of AYUSH, CDSCO, ASCI, state AYUSH licensing authorities, marketplaces, and EU / US / Gulf / ASEAN export regulators. Track sample status through YLIMS.

Turnaround Time

Panel Standard TAT Express
Single marker assay on established validated method (HPLC) 5 to 7 business days Available
Multi-marker assay panel on established methods 5 to 7 business days Available
HPTLC marker quantification (pharmacopoeial reference) 5 to 7 business days Available
Batch-release marker assay (routine) 5 to 7 business days Available
Custom method development 2 to 3 weeks On request
Full ICH Q2(R1) method validation 4 to 6 weeks On request
LC-MS/MS confirmation for trace markers 7 to 10 business days On request

Who Needs Marker Compound Analysis

  • AYUSH-licensed manufacturers preparing licence dossiers where the per-preparation API / UPI / SPI monograph specifies a marker assay limit.
  • Brands making quantitative label claims ("standardised to X% withanolides", "95% curcuminoids", "10% andrographolide") requiring documented evidence for ASCI advertising defence.
  • Herbal supplement and nutraceutical brands launching on Amazon, Flipkart, Nykaa, Myntra, and other marketplaces requiring marker assay data for the product listing dossier.
  • Private label contract manufacturers building marker assay data packs for brand-owner handover and downstream batch release.
  • Exporters supplying EU and US markets where USP and EP herbal monographs specify marker compound quantification for the import dossier.
  • Brands launching reformulated or improved formulations needing fresh marker assay data on the new batch profile.
  • QC and batch-release teams running routine marker assay on every production batch for in-house specification compliance.
  • Brands contesting an ASCI label-claim challenge, marketplace listing rejection, or CDSCO finding on marker content — full re-assay on documented NABL chain of custody.

Why Auriga for Marker Compound Analysis

HPLC + HPTLC Under One Roof

HPLC platforms across the Arbro Group provide capacity for routine, high-volume batch-release marker assay. HPTLC pairs alongside for the pharmacopoeial chromatographic confirmation that AYUSH and EP monographs reference.

Pharmacopoeial Method Alignment

Methods follow the per-preparation API, UPI, SPI, USP, and EP herbal monograph. Where the monograph is silent or the marker is proprietary, Auriga develops and validates a custom method per ICH Q2(R1).

Common AYUSH Markers Ready to Test

Established validated methods on file for withanolides, curcuminoids, andrographolide, piperine, gymnemic acid, boswellic acids, glycyrrhizin, bacosides, ginsenosides, and other commonly requested markers — fast turnaround on routine batch assay.

ASCI Label Claim Substantiation

Quantitative label claims need documented evidence. NABL-accredited marker assay against certified reference standards generates the ASCI-defensible substantiation file for any "standardised to X%" claim on label or marketing.

First ISM&H-Licensed Herbal Lab

Delhi HQ is India's first herbal testing lab licensed by the Directorate of ISM&H, AYUSH approved since 2004 (DTL-01 A&U), and holder of the Unani licence. The audit trail Ministry of AYUSH, CDSCO, and export reviewers look for in a marker assay partner.

Integrated with Stability and Fingerprinting

Marker assay flows seamlessly into stability tracking (marker decay across pull points) and standardisation (HPTLC fingerprint pairing) — same SPOC, same NABL chain of custody, consolidated reporting.

Frequently Asked Questions

What is marker compound analysis?
Marker compound analysis is the quantitative identification and assay of a NAMED bioactive compound (or group of related compounds) in a herbal raw material or finished AYUSH preparation. Typical examples include withanolides in ashwagandha, curcuminoids in turmeric, andrographolide in kalmegh, piperine in black pepper, gymnemic acid in gymnema, boswellic acids in salai guggul, and glycyrrhizin in licorice. The assay quantifies the actual percentage content against a certified reference standard.
How is marker compound analysis different from phytochemical screening?
Phytochemical screening identifies which CLASSES of phytoconstituents are present (alkaloids, flavonoids, tannins, saponins, etc.) — qualitatively or semi-quantitatively. Marker compound analysis quantifies SPECIFIC named compounds within a class — for example, the percentage of withanolides in an ashwagandha extract or the percentage of total curcuminoids in a turmeric product. Screening is the first layer; marker assay is the quantitative layer that follows.
Which methods are used for marker compound assay?
High-Performance Liquid Chromatography (HPLC) with UV, DAD, or fluorescence detection is the default method for most marker compounds, and HPLC-MS/MS is used for trace-level or structurally similar marker resolution. High-Performance Thin Layer Chromatography (HPTLC) is the pharmacopoeial reference method for many AYUSH and herbal monographs and is used in parallel for chromatographic confirmation and fingerprint pairing. Methods are validated per ICH Q2(R1).
Can Auriga develop custom marker compound methods?
Yes. Where the relevant API / UPI / SPI / USP / EP monograph already specifies a marker compound assay method, that method is followed. Where the monograph is silent or for a novel proprietary marker, Auriga develops and validates a custom HPLC or HPTLC method per ICH Q2(R1) — specificity, linearity, accuracy, precision, LOD, LOQ, and robustness. The validated method becomes part of the client dossier for batch release and future audits.
Why is marker compound assay needed for label claims?
"Standardised to 5% withanolides", "95% curcuminoids", "10% andrographolide" — these are quantitative label claims that ASCI and CDSCO require to be backed by analytical data. Without a NABL-accredited marker assay against a certified reference standard, the claim is unsubstantiated and exposes the brand to ASCI advertising orders, marketplace delisting, and CDSCO regulatory action. Marker compound assay generates the documented evidence required for the claim.
How long does marker compound testing take?
Standard HPLC marker compound assay against a certified reference standard takes 5 to 7 business days from sample receipt for established methods. HPTLC marker quantification takes the same duration. Custom method development plus full ICH Q2(R1) validation takes 4 to 6 weeks depending on complexity. Routine batch-release marker assay on an established validated method runs in 5 to 7 business days.

Get Your Marker Compound Assay Quote

NABL-accredited HPLC and HPTLC marker compound assay at Delhi HQ (first ISM&H-licensed lab). Withanolides, curcuminoids, andrographolide, piperine, gymnemic acid, boswellic acids, glycyrrhizin, bacosides, ginsenosides, and custom markers. Accepted by Ministry of AYUSH, CDSCO, ASCI, and EU / US / Gulf export regulators.

Call Now Get a Quote

Type to search services, tests, and locations…